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WORLD INTELLECTUAL PROPERTY ORGANIZATION
International Bureau

per

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(51) International Patent Classification 5

G01N 21/00, 21/03, 21/47
G01N 21/55, 31/00, 33/00

(11) International Publication Number: WO 92/15859

(43) International Publication Date: 17 September 1992 (17.09.92)

(21) International Application Number:

PCT/US92/01733

(22) International Filing Date:

(30) Priority data:
661,811

27 February 1992 (27.02.92)

27 February 1991 (27.0Z9I) US

(71) Applicant: BOEHRINGER MANNHEIM CORPORA

TION [US/US); 9115 Hague Road, P.O. Box 50528, In-
dianapolis, IN 46250-0528 (US).

(72) Inventors: ADRIAN, Bradford, C. ; 2129 Ivy Drive, An-

derson, IN 4601 1 (US). ANDERSON, Joe, E. ; 709 Sun-
set Boulevard, Greenwood, IN 46142 (US). ARBUCK-
LE, Steven, R. ; 6435 Breamorc Road, Indianapolis, IN
46220 (US). BECK, Timothy, L. ; 5136 S. 450 E., Mid-
dletown, IN 47356 (US). BOYD, William, Ronald ; 7773
Paddington Lane West, Indianapolis, IN 46268-4703
(US). GORADIA, Prafulla, D. ; 8205 Old Prairie Court,
Indianapolis, IN 46256 (US). GRANT, Michael, E. ;
1500 Dover Highway, P.O. Box 1929, Sand Point, ID
83864 (US). GRAY, Russell, T. ; 1069 East Clifford
Road, Brownsburg, IN 461 12 (US). RIEDEL, Richard ;
10012 Holaday Drive, Carmel, IN 46032 (US). ROB-
BINS, Tyrie, R. ; 1729 Handball Lane, Apt. A, P.O. Box
501152, Indianapolis, IN 46260 (US). SCOPATZ, Ste-
phen, D. ; 734 East 73rd Street, Indianapolis, IN 46240
(US). SOWA, Sandra, E. ; 15494 Martha Street, For-
tville, IN 46070 (US). STOUGHTON, John, W. ; 5908
University, Indianapolis, IN 46219 (US). YATES, Ro-
bert, C. ; 6855 Barr Will Drive, Indianapolis, IN 46220
(US). ^

(74) Agents: CONARD, Richard, D. et al.; Barnes & Thorn-
burg, 1313 Merchants Bank Building, 11 South Meridi-
an Street, Indianapolis, IN 46204 (US).

(81) Designated States: AT (European patent), BE (European
patent), CH (European patent), DE (European patent),
DK (European patent), ES (European patent), FR (Eu-
ropean patent), GB (European patent), GR (European
patent), IT (European patent), JP, LU (European pa-
tent), MC (European patent), NL (European patent), SE
(European patent).

Published

With international search report.

(54) Title: APPARATUS AND METHOD FOR ANALYZING BODY FLUIDS

(57) Abstract

A method and apparatus for verifying the operating accuracy of an instrument (10) for detecting the concentration of a
medically significant component of a body fluid. The method and apparatus includes inserting into the instrument (10) a verifica-
tion substrate (106) having a known remission, a mechanism for energizing the radiation source (182), detecting with a radiation
detector (300) the remission from the verification substrate (I06X and displaying on a display (76) associated with the instrument
(10) an indication that the known remission was detected by the radiation detector (300).

FOR THE PURPOSES OF INFORMATION ONLY

Codes used .o identify Stat* pany to the PCT on the front pages of pamphlets publishing international
applications under I he PCT.

AT Austria

AU Australia

BB Barbados

BE Belgium

BP Burkina ba$t>

BC . Bulgaria

BJ Bcnro

BR Brazil

CA Canada

CP Central African Rcirobfic

CG Congo

CM Switzerland

CI Cote dlvoirc

CM Cameroon

CS CVrchnsknrakia

DE Germany

DK Denmark

ES Spain

Fi-
re

CA
CB
CN
CR
HU
IE
IT
JP
HP

U
LK
LU

MC
MC

Finland

France

United Kingdom

Guinea

Greece

Hungary

Irdand

Italy

Democratic People's Republic
of Korea

Republic oT Korea
IJecbfenstcin
Sri Lanka
Luxembourg

Mali

MN
MR

Mongolia
Mauritania

Malawi

Netherlands

Norway

Poland

Romania

Russian Federation

Sudan

Sweden

Senegal

Soviet Union

Chad

Togo

United States of America

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APPARATUS AMD METHOD FOR ANALYZING BODY FLUIDS

This invention relates to apparatus and methods
5 for reading the concentration of a medically significant
component of a biological fluid from a test strip.

Industrial Applicability

The invention is disclosed in the context of an
10 apparatus and a method for reading the concentration of
glucose in blood reacted on a test strip with a chemistry
with which the strip has previously been treated.

PagfrgrPMPd ftrt

15 The difficulty many people have with preparing

test strips treated with chemistries with bodily fluids
such as blood and urine is known. Many users of such
strips have poor eyesight owing to diabetes, to age, and
to other causes as well. .Many users have reduced

20 dexterity or strength in their hands owing to age and to
other causes. Frequently these causes are the reasons
why these users are testing their bodily fluids for, for
example, glucose concentration to begin with.

The problems . with such strips only begin with

25 dosing the strips with the bodily fluid or fluids to be
analyzed. The chemistries are reactants with the
medically significant component (s) of the fluids. These
reactants react with the medically significant
component (s) resulting typically in some colorimetric

30 indication of the concentration of the medically

significant component of the fluid. However, these
reactions continue, typically for extended times, until
all of the reactants have reacted. Consequently, it is
generally necessary to time the reaction of the medically

35 significant component with the strip chemistry so that a

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colorimetric comparison of the reacted strip chemistry to
a standard on a color chart can be made at some
established time after the reaction is initiated by
depositing the fluid on the strip. Otherwise, if the
reaction is not permitted to proceed long enough, or is
permitted to proceed too long, the color corresponding to
the extent of the reaction will not match the correct
standard on the chart.

In addition to potential problems with how long
the chemistry on the strip and the medically significant
component of the body fluid are permitted to react, there
are problems with many of such chemistry systems with how
much of the body fluid is applied to the strip, since
incorrect amounts of the reactants may affect the
15 validity of the test as adversely as errors in the timing
of the reaction. Either way, a false reading, sometimes
with dire consequences, will result.

The present invention makes use of an endpoint
chemistry system of the type described in U.S. Patent
20 4,929,545. The disclosure of U.S. Patent 4,929,545 is
incorporated herein by reference. The advantages of an
endpoint chemistry are clear. For the user who
frequently has poor eyesight and/ or manual dexterity,
there is no need to be concerned about how long the
25 reaction has proceeded. The reaction reaches an endpoint
in relatively short order after which there is no
significant shift in the color of the reaction products
on the strip. In addition, the architecture of the strip
described in U.S. S.N. 07/661,788, filed February 27,
30 1991, IMPROVED TEST STRIP, naming as inventors McCroskey,
Freitag, Smith, Dean, Secrest and Bouse, and assigned to
Boehringer Mannheim Corporation, is such that the proper
dose of the body fluid, the biologically significant
component of which is to be reacted with the chemistry on
35 the strip, will always be available for the reaction.

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Any excess is wicked away from the reaction site by the
strip architecture. Thus, all the user need do is be
sure enough of the bodily fluid is present at the
reaction site on the strip to react with the chemistry
5 with which the strip is treated. The disclosure of

U.S. S.N. 07/661,788 is incorporated herein by reference.

Disclosure of Invention

According to one aspect of the invention, a

10 method and an apparatus are provided for verifying the
operating accuracy of an instrument for detecting the
concentration of a medically significant component of a
body fluid. "The instrument operates by determining the
remission of a reacted chemistry contained on a substrate

15 after the chemistry has reacted with the medically

significant component of the body fluid. The instrument
includes a radiation source, a radiation detector and a
pathway from the radiation source to the chemistry and
from the chemistry to the radiation detector when the

20 substrate is properly inserted into the instrument. The
remission of the chemistry determines the radiation
detected by the radiation detector. The method and
apparatus comprise the step of inserting into the
instrument a verification substrate having a known

25 remission, the steps of and means for energizing the
radiation source, detecting the remission from thi
verification substrate, and displaying on a display
associated with the instrument an indication that the
known remission was detected by the radiation detector.

30 Illustratively according to this aspect of the

invention, the instrument comprises a port for removably
receiving non-volatile memories containing
instrument-initializing parameters related to the
characteristics of specific batches of the chemistry.

35 The chemistry is subject to fluctuation from batch to

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batch. The invention further comprises the steps of and
means for providing a non-volatile instrument operating
accuracy verifying memory in which parameters related to
the characteristics of the verification substrate are
stored, and inserting the operating accuracy verifying
memory before the step of inserting the verification
substrate into the instrument.

Additionally illustratively according to this
aspect of the invention, the instrument further includes
a second radiation source, a second radiation detector
and a second pathway from the second radiation source to
the substrate and from the substrate to the second
radiation detector when a substrate is inserted into the
instrument. The method and apparatus further comprise
15 the steps of and means for energizing the second

radiation source, detecting the remission therefrom using
the second radiation detector, and displaying on the
display an indication whether a substrate has been
inserted into the instrument based upon the remission
detected by the second radiation detector.

Further illustratively according to this aspect
of the invention, the display provides a number of
symbols. The method and apparatus further comprise the
step of and means for energizing multiple symbols of the
display after the step of displaying on the display an
indication whether a substrate is inserted into the
instrument based upon the remission detected by the

second radiation detector.

Further illustratively according to this aspect
of the invention, the instrument comprises an audio
source. The method and apparatus further comprise the
step of and means for energizing the audio source after
the step of displaying on the display an indication
whether a substrate is inserted into the instrument based
upon the remission detected by the second radiation

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detector.

According to another aspect of the invention, a
method and an apparatus are provided for testing the
operation of an instrument for detecting the
5 concentration of a medically significant component of a
body fluid. The instrument operates by determining the
remission of a reacted chemistry contained on a substrate
after the chemistry has reacted with the medically
significant component of the body fluid. The instrument

10 includes a radiation source, a radiation detector and a
pathway from the radiation source to the substrate and
from the substrate to the radiation detector when the
substrate is inserted into the instrument* The method
and apparatus comprise the steps of and means for

15 energizing the radiation source, detecting the remission
therefrom, and displaying on a display associated with
the instrument an indication whether a substrate is
inserted into the instrument based upon the detected
remission.

20 Illustratively according to this aspect of the

invention, the display provides a number of symbols. The
method and apparatus further comprise the step of and
means for energizing multiple symbols of the display
after the step of displaying on the display an indication

25 whether a substrate is inserted into the instrument based
upon the detected remission.

Additionally illustratively according to this
aspect of the invention, the instrument further comprises
an audio source* The method and apparatus further

30 comprise the step of and means for energizing the audio
source after the step of displaying on the display an
indication whether a substrate is inserted into the
instrument based upon the detected remission.

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Rrief pepgriptiion nf Drawings

The invention may best be understood by
referring to the following detailed description and
accompanying drawings which illustrate the invention.

5 the drawings:

Figs. 1-8 illustrate exploded perspective
views, from various different angles, of various
components of an instrument constructed according to the

present invention;
10 Fig. 9 illustrates a partly block and partly

schematic circuit diagram of the electric circuit of the
instrument illustrated in Figs. 1-8;

Fig. 10 illustrates a type of flow diagram
useful in understanding the operation of the instrument

-.1.

15 illustrated in Figs. 1-8;

Fig. 11 illustrates a % remission versus time
curve useful in understanding the operation of the
software of the instrument of Figs. 1-9; and

Fig. 12 illustrates another % remission versus
20 time curve useful in understanding the operation of the
software of the instrument of Figs. 1-9.

Mrvte For carr ying » »» the Invention

Referring now to Figs. 1 and 8, an instrument

25 10 according to the invention includes a case 12 having a
front portion 14, a rear portion 16, a key housing
portion 18 and a strip carrier holder portion 20. A
printed circuit board 22, the contents of which will be
considered in more detail in the discussion of Fig. 9, is

30 sandwiched generally between the front and rear portions
14, 16, respectively. Front portion 14 includes a relief
24 of generally trapezoidal configuration at the center
of which is a generally circular opening 26. A generally
right circular cylindrical stem 28 extends downwardly

35 from the underside of front portion 14 beneath opening

WOW/15859

PCT/US92/01733

26. This stem 28 slidably receives a stein 30 provided on
the back of an ON/ OFF button 32 of the sane shape as
relief 24. The lover end of stem 30 is split axially and
somewhat frustoconical in configuration so that button 32
5 is captured in relief 24 when stem 30 is pushed into

opening 26 until the split, frustoconical end 36 of stem
30 clears the bottom end 38 of stem 28. The portion of
stem 30 above end 36 is somewhat longer than stem 28 so
that some movement of button 32 vertically in relief 24

10 is possible.

Front casing portion 14 also includes a wall 40
inside of, and parallel with, a region 42 of an end wall
thereof. Wall 40 includes a vertically extending groove
44 open at its bottom 46 and with a semicircular top 48.

15 A memory button 50 has ribs 52 on its back wall spaced
apart slightly less than the width of groove 44. Button
50 excluding ribs 52 is slightly thicker than the space
between wall 40 and region 42. The f lexible resin
construction of front portion 14 and a circular opening

20 54 of slightly larger diameter than button 50 in region
42 permits the wall 40 to flex away from region 42 as
button 50 is forced into the space between them and snaps
into place protruding through opening 54. A flange 56 on
button 50 keeps it from going all the way through opening

25 54 and falling from front portion 14.

The front and rear portions 14, 16 include
respective, cooperating, somewhat arcuate cutouts 60, 62
(Figs. 1, 6 and 8), for key housing portion 18. Key
housing portion 18 is designed to receive an

30 electronically readable information carrier, or key, 64
(Fig. 2) of the type described in U.S. Patent 5,053,199.
The disclosure of U.S. Patent 5,053,199 is incorporated
herein by reference. Front and rear portions 14, 16 also
include cooperating cutouts 68, 70 (Figs. 1, 6 and 8) for

35 receiving the strip carrier holder portion 20- Front

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portion 14 also includes a window 74 (Figs. 1 and 8)
around which a liquid crystal display 76-supporting bezel
78 (Figs. 3 and 7) fits on the inside of front portion
14. Bezel 78 mounts the LCD 76 so as to be visible
5 through window 74 and provides the necessary electrical
connections 79 to LCD 76.

The back portion 16 of the case 12 also
includes means for mounting a piezoelectric beeper
transducer 80 (Fig. 6) and for providing electrical

10 contact 81 thereto and a battery housing cutout 82 having
a pivotally mounted door 84 for convenient insertion and
removal of a six-Volt battery 86.

The lips 88, 90 of front and back portions 14,
16, respectively, are complementarily configured to snap

15 together. As further insurance against their

inadvertently coming apart, a self tapping screw 92 (Fig.
1) through back portion 16 and into a stem 94 molded on
the inside of front portion 14 holds portions 14, 16
together. Screw 92 extends through a hole 96 provided

20 therefor in printed circuit board 22, which, along with
the configurations of the interiors of front and back
portions 14, 16, holds board 22 in place.

The strip carrier holder portion 20 includes an
outer case portion 100 provided with grooves 102 (Fig. 4)

25 on its top and bottom surfaces to aid in gripping it and
snapping it into and out of engagement with the front 14
and back 16 case portions. Case portion 100 is provided
with an opening 104 for inserting chemistry strips 106,
the remissions of which are to be read, into the

30 instrument 10. The margins 108 of opening 104 are
somewhat funnel-shaped to assist in insertion of the
strips 106 into the instrument 10 in the correct
orientation. A pair of somewhat pawl^shaped members 110
extend rearwardly of case portion 100 beneath opening

35 104. Members 110 define between them a slot 112 which

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opens into a somewhat equilateral triangular region 114
near their remote ends 116, then closes back to its slot
configuration, and then opens into a somewhat funnel
shape 118 adjacent the remote ends 116 of members 110. A
5 strip carrier body 120 includes a lower web portion 122
along each of the opposite sides of which extend two
guide ribs 124. Web portion 122 is only slightly thinner
than slot 112 is for most of its length. Guide ribs 124
are spaced apart only slightly further than the vertical

10 thickness of each of members 110. These dimensions

permit strip carrier body 120 to be slid into the slot
112 defined between members 110. A triangular horizontal
cross section projection 126 spaced an appropriate
distance along web portion 122 on each side thereof

15 between guide ribs 124 cooperates with region 114 on case
portion 100 to lock strip carrier body 120 between
members 110.

Near its end remote from case portion 100,
strip carrier body 120 includes a pair of horizontally

20 projecting ears 130, each of which is provided with an
elongated slot 132. Slots 132 extend generally
transversely to the directions of motion of strips 106 as
the strips are inserted into opening 104 and into the
strip carrier holder 20 and removed therefrom. A lift

25 134 includes a pair of vertically, oppositely extending
trunnions 136 which engage in respective slots 132 to
permit lift 134 to move away from strip carrier body 120
as a strip 106 to be read is inserted therebetween. Lift
134, in turn, includes a pair or horizontally extending

30 ears 138 at its forward end opposite the end at which
trunnions 136 are provided. Each ear 138 is provided
with a vertically extending circular cross section hole
140. A high reflectance (remission) white tile 142 is
provided with a pair of trunnions 144 by which it is

35 pivotally attached, by insertion of trunnions 144 into

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respective holes 140, to lift 134. Directly across from
the point 146 at which white tile 142 projects through an
opening 150 provided therefor in lift 134, strip carrier
body 120 is provided with a slot 152. Strip carrier body
5 120 is also provided with another slot 154 between slot
152 and case portion 100, and with a frustoconical relief
156 (illustrated only in Fig. 1) on the side thereof
opposite the side to which lift 134 is attached.

An optics assembly 160 (Figs. 1, 3 and 5)

10 mounted on the printed circuit board 22 cooperates with
the strip carrier holder portion 20. The cooperation of
these two components negates any possible misalignment
errors between the optics and the strips 106. This
cooperation is aided by the designs and tolerances of

15 some of the molded plastics parts from which the strip
carrier holder portion 20 and optics assembly 160 are
largely constructed. These designs and tolerances permit
the components of the strip carrier holder portion 20 and
optics assembly 160 which must be properly aligned for

20 accurate reading of the reacted strips' 106s' remissions
to align properly when the strip carrier holder portion
20 is assembled into the instrument case 12.

Optics assembly 160 includes an optics housing
162. Housing 162 houses a leaf spring i68 and, across

25 from spring 168 , a wall 170 against which the spring 168
forces the strip carrier body 120 to position it and its
related components 134, 142 and a strip 106 carried
thereby properly relative to the instrument 10 »s optics.
A frustoconical projection (not illustrated) projecting

30 toward spring 168 from wall 170 adjacent the inner end
171 of housing 162 engages relief 156 on strip carrier
body 120 when strip carrier body 120 is correctly
positioned in optics housing 162. A pair 174, 176 (Fig.
3) of transparent plastic prisms, molded as a single

35 piece 177, are mounted on printed circuit board 22 in

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separate internal regions 178, 180, respectively, (Fig.
5) of housing 162. A light emitting diode 182 is mounted
on board 22 and fitted into an LED adapter 184 which, in
turn, is fitted into an LED socket 186 provided on
5 housing 162. LED 182 is the initiation, or "upstream"
end, of a glucose measurement channel 164.

Wall 170 is provided with a vertical slit
opening 190 opposite the opening of socket 186 into
housing 162. In the assembled optics assembly 160, this

10 slit opening 190 is directly adjacent prism 174, the
smaller of the two prisms provided by piece 177. In
order to avoid receiving the direct reflected light from
the reacted test chemistry on a strip 106, prism 174 is
oriented at an angle to the surface of the strip 106

15 other than the angle of incidence of light from LED 182
onto, or the angle of reflection of light from LED 182
from, strip 106. Illustratively, prism 174 is oriented
at an angle of about 77 ° to the surface of strip 106. .
This increases the likelihood that light received by

20 prism 174 is not direct reflected light, but rather

ambient remission light, from the reacted chemistry on
strip 106. This diffuse light is a better gauge than
direct reflected light of the end point of the reaction
between the glucose in blood applied to strip 106 and the

25 chemistry with which strip 106 is treated. Thus, this
ambient remission light is a better gauge of the
concentration of the glucose content of the blood.

Prism 176 is oriented directly adjacent a slit
opening 191 through wall 170 in the assembled optics

30 assembly 160. The problem of obtaining a diffuse or
remission light component of the light reflected from
strip 106 is not so great with the light entering prism
176 as it is with the light entering prism 174 because
the light entering prism 176 is used only to determine

35 whether there is a strip in strip carrier body 120, and,

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if so, whether the strip is properly oriented with its
chemistry immediately opposite opening 190 and prism 174.
Since prism 176 is not in the chemistry reading channel
164 , the remission reading from it is not so critical.
5 Both of prisms 174 , 176 have curved faces

facing strip 106. These curved faces function as lenses
to focus the light remissions entering the prisms on the
devices which detect these remissions. The lenses
incorporated into prisms 174, 176, in other words, have

10 focal lengths equal to the distances from the lenses to
their respective regions of interest on the strip 106 and
also equal to the distances from the lenses to their
respective detector devices.

Turning now to Fig. 9, the operation of

15 instrument 10 is controlled by a microcomputer (mc) 200
such as the NEC type jiFD75P308 pc. All subsequent
references herein to pin and terminal numbers and names
will be to the pin and terminal numbers and names of the
specific integrated circuits and other devices identified

20 herein as exemplary. It is to be understood, however,
that other integrated circuits may exist which are
equally suited to provide the functions required by
instrument 10. The clock f or po 200 is a 4.19 MHz
crystal 202 which is coupled across terminals X1-X2

25 thereof. The terminals of crystal 202 are also coupled
through respective 33pF capacitors to ground, the V DI >
supply for mc 200 is provided by a PNP transistor 204
such as a BC858C, the base of which is coupled through a
62K0 resistor 206 to terminal P4.1 of jxc 200. The

30 collector of transistor 204 is coupled to positive

battery voltage (+6VDC) , hereinafter referred to as VBAT.
V DD appears at the emitter of transistor 204. The
collector of transistor 204 is coupled to its emitter by
the parallel combination of two 200 n resistors. The

35 cathode of a diode 208 is coupleid to the emitter of

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transistor 204. The anode of diode 208 is coupled to
ground. Diode 208 illustratively is a type 1N4148 diode.

The RESET terminal of 200 is coupled to the
collector of a transistor 210 and through a 10K n
5 resistor to V D0 . The emitter of transistor 210 is

grounded. Its base is coupled through a 22KH resistor
212 to the junction of a .IjiF capacitor 214 and a lMfl
resistor 216. The other terminal of capacitor 214 is
coupled to VBAT. The other terminal of resistor 216 is

10 coupled to ground.

An electronic log book mode (ELB) connector 220
has three terminals. A first of these, 222 , is coupled
through a 10KQ resistor to terminals P 3.0/LCDCL and
P 0.0/INT4 of mc 200. Terminal 222 is also coupled to

15 ground through the parallel combination of a 680pF

capacitor and a 220KO resistor. Terminal 224 is coupled
through a lOKfl resistor to terminal P3.2 of /ic 200 , and
to ground through the parallel combination of a 680pP
capacitor and a 220KO resistor. Terminal 226 is coupled

20 to ground.

The eight terminals 231-238 of the key housing
portion 18 are coupled, respectively, to: /ic 200's
terminal P7.3/KR7; mc 200's terminal P7.2/KR6; mc 200's
P7.0/KR4; pc 2 00 f s terminal P6. 3 /KR3; ground; one

25 terminal of a 220K0 resistor 240, the remaining terminal
of which is coupled to terminal 234; nothing (blank); and
terminal 236.

A number of variables exist which affect the
reading of the reacted chemistry on a strip 106. For the

30 reading to be as free of errors as instrument 10 can make
it, these variables must be accounted for to the extent
possible by instrument 10 in the process of calculating
the end point remission of the reacted chemistry. One of
these variables is humidity, and it is taken into

35 consideration by a humidity sensor 242 of standard

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configuration coupled between ground and an input
terminal P0.3/SI/SB1 of fie 200. Humidity sensor 242 is
also coupled through a Utti resistor 244 and a .OljiF
capacitor 246 to ground. VBAT is supplied to the emitter
5 of a PNP transistor 248, illustratively a BC858C. The
collector of transistor 248 is coupled to key housing
portion 18 »s connectors 236 and 238 and to the junction
of resistor 244 and capacitor 246.

An internal EEPROM 250 has its CS, SK, DI and

10 DO terminals coupled, respectively, to the P7.1/KR5,

P7.2/KR6, P7.0/KR4 and P6. 3 /KR3 terminals of pc 200. The
Vcc and ORG terminals of internal EEPROM 250 are coupled
to the collector of transistor 248. The GND terminal of
internal EEPROM 250 is coupled to ground. Internal

15 EEPROM 250 illustratively is a catalyst Semiconductor

type CAT93C46 integrated circuit, as is the integrated

circuit in code ROM key 64.

A series string of an 8. 2Kli resistor 252, a

10KI1 resistor 254, a 10K11 resistor 256, and a 10K11
resistor 258 is coupled between terminal P6.1/KR2 of
/tc200 and ground. The junction of resistors 252, 254 is
coupled to terminals VLC0 and BIAS of yc 200. The
junction of resistors 254 and 256 is coupled to terminal
VLC1 of mc 200. The junction of resistors 256 and 258 is
25 coupled to terminal VLC2 of pc 200;

Transducer 80 is coupled across terminal
P2.3/BUZ of mc 200 and ground. A diode 260 is coupled
across transducer 80 with its anode coupled to ground and
its cathode coupled to terminal P2.3/BUZ. Another diode
30 262 has its anode coupled to terminal P2.3/BUZ and its
cathode coupled to V DD .

The COM0-COM2 and DS10-DS0 terminals,
respectively, of yc 200 are coupled to respective
terminals of the same names, pins 1-14, of LCD 76.
35 An infrared strip 106 sensor channel 166

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includes an LED 264 and a light sensitive transistor
(LST) 266 separated by a partition in a common housing
(not shown) . The larger prism 176 is mounted on printed
circuit board 22 so that its bottom surface rests
5 directly on the top surface of the housing in which LED
264 and LST 266 are housed* LED 264 and LST 266
illustratively are a Toshiba type TLP908 integrated
circuit. Light from LED 264 shines upward through the
bottom of the larger prism 176 and is reflected out

10 through the lens of prism 176 onto the strip 106. The

reflected light returns through the lens and is reflected
downward within the prism 176 and out the bottom thereof
where it is received by LST 266. The resultant
conductivity of LST 266 corresponds to a certain

15 percentage remission of the light from LED 264. That

percentage remission establishes whether a strip 106 is
present in strip carrier body 120 and, to an extent,
whether that strip 106, if present, is properly oriented.

The way the strip 106 and strip 106 orientation

20 are detected is as follows. Light returning in channel
166 to the base of LST 266 causes it to conduct. A
current mirror including NPN transistors 268 and 270 in
conventional current mirror configuration provides equal
currents through the collectors of these two transistors

25 in response to current flow in the emitter of LST 266. A
.47MF capacitor 272 is coupled across the collector and
emitter of transistor 270 and discharges at a rate
determined by the amount of light falling on the base of
LST 266 to which LST 266 is sensitive. This

30 configuration subtracts from the initial voltage across
capacitor 272 the integral of the light falling on the
base of LST 266. Current is supplied to LED 264 for a
predetermined, set period of time. The remission from
strip 106 to the base of LST 266 determines how deeply

35 discharged capacitor 272 becomes. Capacitor 272 is then

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charged from a constant current source for a period of
time which is measured using the system clock, until
capacitor 272 has recharged to some reference voltage.
The length of the period that capacitor 272 takes to
recharge to reference voltage is a period of time, a
number of strokes of the system clock, and converts to a
digital value the percentage remission of channel 166.
This translates into the presence or absence of a strip
106 in the strip carrier body 120 and, to an extent, its
orientation in strip carrier body 120. The instrument
10, once it has established that a strip 16 is present in
the strip carrier body, next decides whether the strip
106 is properly oriented with its reagent pad in front of
slot 190 and prism 174, or whether the strip 106 is
15 backward or upside down. Of course, the strip

architecture must be such that different ranges of
percentage remission readings are presented for these
different strip 106 orientations, and this is so. see
U.S. S.N. 07/661,788.
20 to accomplish these objectives, the anode of

LED 264 is coupled to VBAT and its cathode is coupled to
the collector of a transistor 276, which illustratively
is a type BC848C NPN transistor. The emitter of
transistor 276 is coupled through an 820 feedback
25 resistor to ground. The base of transistor 276 is
provided with periodic LED 264 drive signals from #
terminal P5.1 of /*c 200. The base of transistor 276 is
also coupled through two diode-connected temperature
compensation transistors 280, 282 in series to ground.
Transistors 268, 270, 280, 282 illustratively are a type
MC3346D quad transistor integrated circuit. The emitter
of LST 266 is coupled to the collector and bass of
current mirror transistor 268, and to the base of current
mirror transistor 270. The collector and base of
transistor 268 and the base of transistor 270 are also

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coupled to terminal P5.0 of /ic 200. The emitters of
transistors 268 , 270 are grounded. The collector of
transistor 270 , in addition to being coupled to capacitor
272, is coupled to the inverting (-) input terminal of a
5 difference amplifier 286 , and to the collector of a PNP
transistor 288 such as a type BC858C transistor. The
output terminal of difference amplifier 286 is coupled to
the P3.1/ SYNC terminal of 200. The emitter of
transistor 288 is coupled to terminal P5.3 of no 200.

10 The base of transistor 288 is coupled to the output
terminal of a difference amplifier 290.

The inverting (-) and non-inverting (+) input
terminals of difference amplifier 290 are coupled through
a 20KO resistor and a 150H resistor, respectively, to the

15 collector of LST 266. A 5.1KO resistor is coupled from
the base of transistor 276 to the collector of LST 266 as
veil. The collector of LST 266 is coupled to the + input
terminal of a difference amplifier 294, the - input
terminal of which is coupled through a 150KH resistor to

20 terminal P6.0/KRO of jic 200. The output terminal of

difference amplifier 294 is coupled to terminal P3.3 of
/xc 200. The - input terminal of difference amplifier 294
is also coupled through a . 01/xF capacitor to ground.

Turning now to the mechanism and electronics by

25 which the remission of the reagent pad portion of strip
106 is read when a strip 106 is properly inserted into
strip carrier body 120, LED 182 is the beginning of
channel 164* The anode of LED 182 is coupled to VBAT and
its cathode is coupled to the collector of an NPN

30 transistor 298. Transistor 298 illustratively is a type
BC848C transistor. The emitter of transistor 298 is
coupled through a 12 on feedback resistor to ground. The
base of transistor 298 is coupled to terminal P5.2 of c
200, and through a 20KH resistor to the + input terminal

35 of difference amplifier 294. The remission of the

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reagent pad of a strip 106 is supplied to a photosensor
300, such as a Siemens type TFA1001W integrated
photosensor. Photosensor 300 is mounted in closely
spaced relation to the bottom of the smaller prism 174 so
5 that remissions from the chemistry region of strip 106
that enter the lens surface of prism 174 are reflected
down through it and exit from its bottom into photosensor
300.

Power for photosensor 300 is provided through a

10 PNP transistor 302, which illustratively is a type BC858C
transistor. The emitter of transistor 302 is coupled to
VBAT. Its base is coupled through a 62KO resistor to
terminal P4. 2 of pc 200. Its collector is coupled to
ground through a 22jtF tantalum capacitor 304. The

15 voltage vbl across capacitor 304 is coupled across
terminals + VS and - VS of photosensor 300. A .01/iF
capacitor is also coupled across terminals + VS and - VS.
The VSTAB and FCOMP terminals of photosensor 300 are
joined through a IMG resistor. The VSTAB terminal is

20 also coupled to the + input terminal of a difference
amplifier 308. The - input terminal of difference
amplifier 308 is coupled to its output terminal, making
it an inverting amplifier. The output terminal of
difference amplifier 308 is also coupled to the + input

25 terminal of difference amplifier 294. Difference

amplifiers 286, 290, 294 and 308 illustratively are a
type LM324A quad difference amplifier integrated circuit.

Terminal P6.2/KR2 is coupled through a 220KO
resistor to the anode of a diode 310 which illustratively

30 is a type IN4148. The cathode of diode 310 is coupled to
the INHIBIT terminal of photosensor 300. The conductor
extending between the cathode of diode 310 and the
INHIBIT terminal of photosensor 300 is capacitively
coupled through a 6800 resistor to ground and through a

35 360 resistor to the + input terminal of difference

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amplifier 286. The + input terminal of difference
amplifier 286 is coupled through a 2000 resistor to the +
input terminal of difference amplifier 290. The OUTPUT
terminal of photosensor 300 is coupled to the - input
5 terminal of difference amplifier 286.

One terminal of an ON/OFF switch 312 operated
by ON/OFF button 32 is coupled to ground. The other
terminal of ON/OFF switch 312 is coupled to the Pl.l/INTl
terminal of (ic 200. The PI. 2 /INT2 terminal of pc 200 is

io coupled to one terminal 316 of a memory switch 314

operated by memory button 50. Terminal 316 of memory
switch 314 is coupled through a 220KH resistor to ground.
The other terminal of memory switch 314 is coupled
through a 220KO resistor to the Pl.l/INTl terminal of

15 200.

The symbols which can appear on LCD 76 include
numbers 00. 0 through 99.9, the indications mg/dL
(milligrams per deciliter) , mmol/L (millimoles per
liter), mem (which stands for memory), a battery icon, an

20 icon of a blood droplet being deposited on a strip, the
word code, and an error icon, a box with an W X M through,
it, each quadrant of the box being capable of being
separately energized.

^ Referring now to Fig. 10, the instrument 10 is

25 turned on by depressing ON/ OFF button 32. Instrument 10
actuates prior to release of ON/OFF button 32.
Immediately after the instrument 10 is turned on, it
performs a power-on system integrity test and a battery
voltage test. If the battery 86 voltage is below 4.5

30 volts, a battery low warning (battery icon on LCD 76) is
displayed. If the battery 86 voltage is below 4.2 volts,
the instrument 10 will not turn on. Following being
turned on, all segments of the display 76, including all
icons, are displayed for 2 seconds. If it is enabled,

35 the transducer 80 sounds for the first one/half second of

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this 2 second display check.

After 2 seconds, all segments and icons
disappear and the ROM code number from key 64 and code
icon appear on LCD 76 for 2 seconds, then disappear.
5 During this time, the instrument 10 scales itself using
the remission of white tile 142. Scaling is followed by
the lighting of the strip icon, right arrow icon, and
flashing blood drop icon. This icon display prompts the
user to apply blood to the strip 106 and then to insert

10 the dosed strip 106 into the opening 104 provided
therefor in* instrument 10.

The user applies blood to the strip 106 and
allows it to soak into the strip mesh until it is fully
absorbed. Within two seconds of proper insertion of the

15 strip 106, the instrument 10 deletes the strip icon,

blood drop icon and right arrow icon from display 76, and
begins the timing period for the chemistry in the reagent
pad of strip 106 to react with the medically significant
component, glucose in this example, of the applied blood.

20 Within two seconds of insertion of the strip 106, the
display 76 sequentially displays (in clockwise rotation)
the quadrants on the error or "X" display at a rate of
one segment per half second. No timing need be displayed
on the instrument 10 «s LCD 76 because of the employment

25 of an endpoint chemistry on strips 106. When the strip
106 »s reaction is determined by the instrument 10 to have
reached ah endpoint, the instrument 10 beeps once and
then displays a blood glucose value and the mg/dL icon.
The instrument 10 also displays the strip icon and left

30 arrow icon to prompt the user to remove the reacted strip
106. The glucose result is stored in the newest (first)
memory location, pushing all previously stored glucose
readings down one location in memory.

After the strip 106 is removed, the instrument

35 10 again rescales itself from the white tile 142 to ready

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itself for the next strip 106 reading. The instrument 10
then returns to the dosed strip insertion prompt*

The instrument 10 can verify that an unreacted
strip 106 is acceptable for use. It does this by reading
5 the unreacted strip 106 to make sure that its reagent pad
remission value is within the specified percent remission
limits stored in the code ROM key 64 . Performance of
this check is at the user's discretion. The instrument
10 is capable of performing this check when the

10 instrument is prompting for a dosed strip or during a
memory recall display.

To perform this strip 106 integrity check, the
user removes an unreacted strip 106 from the vial
containing such strips and inserts the unreacted strip

15 106 into the instrument 10 's slot 104 with the reagent

pad facing the optics. Within two seconds after a strip

106 has been inserted, the instrument 10 detects the

presence of a strip 106 and begin its timing display.

During this display, the user must depress the memory

■ ■ • * ».

20 button 50 once. This causes the instrument 10 to perform

the strip 106 integrity check. After the memory button

50 has been pressed, the instrument 10 will read the

strip 1061s remission and compare the strip 106 's

remission against the programmed limits that have been

25 provided by the lot specific ROM key 64.

Strip 106 integrity approval is signaled #
through the strip removal prompt and a single beep.
Strip 106 approval permits the user to proceed with a
test on a reacted strip 106 by prompting for a dosed

30 . strip after the unreacted strip 106 is removed.

Strip integrity errors are signaled through the
display of the flashing error ( w X n ) icon, flashing strip
icon and three, beeps. The instrument 10 remains in this
display state until the bad strip 106 is removed. After

35 strip 106' s removal, the instrument 10 prompts for a

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dosed strip.

Glucose test values are stored automatically
after every test using "first (oldest) in, first deleted"
and "last (newest) in, first recalled" protocols. Once
5 the memory has filled to its thirty reading capacity/
each new reading added causes the oldest reading to be
deleted from memory.

Memory recall mode is accessible from the dosed
strip prompt. Memory recall function is initiated by

10 pushing the memory button 50 once. This displays the
first memory location (1) .

After one second, the display changes to
display the contents (a glucose reading) of the selected
memory location. The display reverts to the memory

15 location display (1 in this example) after 4 seconds. If
no button is pushed, the cycle of memory location and
memory location contents continues to repfeat itself for 5
minutes before the instrument 10 turns itself off . The.
memory display cycle can also be terminated by the

20 insertion of a test strip 106 into the instrument 10.
Recall of the remaining values from memory is
accomplished by pressing the memory button 50 over and
over again until all thirty stored values and their
memory locations have been displayed. Each time the

25 memory button 50 is depressed, the next memory location
is displayed. Memory locations and results cycle to
location 1 ortce the user advances beyond the oldest
value. If fewer than 30 results are stored in memory,
the first location (location 1) is displayed following

30 the last result stored when the memory is advanced beyond
the last result. The memory icon is displayed at all
times during memory recall.

If at any point a strip 106 is inserted, the
instrument 10 reverts to the test/ timing mode. Insertion

35 of a stirip 106 (reacted or unreacted) automatically

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causes the instrument 10 to revert to this mode and
resets memory to the first (newest) location.

The instrument 10 uses the code ROM key 64 as
follows: With the instrument 10 off, the user removes
5 the old ROM key 64 from the instrument 10 and discards
it." A new ROM key 64 is packaged in every supply of
strips 106. The user inserts the new ROM key 64
containing information pertinent to the new supply of
strips 106 into the key housing portion 18 on the

10 instrument 10 prior to turning the instrument 10 on. When
the instrument 10 is turned on, the instrument 10 checks
the integrity of the data contained in ROM key 64 via a
checksum method. If the ROM key 64 data is found to be
questionable, then a code error is displayed. During the

15 performance of a test, prior to the calculation of a new
glucose result, the instrument 10 checks the ROM key 64
to see if it has been changed. If the ROM key 64 has
been changed since the instrument 10 was turned oh, a
code error is displayed. The instrument 10 remains in

20 this display until it either times itself off (5
minutes), or is turned off.

When test results exceed the upper limit
contained in the ROM key 64 , then the message HI is
displayed in place of a numeric result. If the result

25 does not exceed the lower limit contained in the ROM key
64, LO appears on the display. The mg/dL icon is
displayed in both cases.

Instrument 10 verifies the remission of its
white tile 142 and signifies a dirty tile 142 by

30 displaying CLE (for "clean") on display 76. The

instrument 10 does not permit the user to begin a testing
procedure or memory recall from this display. The only
remedy for this error is to turn the instrument 10 off.
This error occurs if the slope calculated from the

35 remission of the white tile 142 is not within instrument

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10 «s internal slope limits, typically +5% to -10% of its
target value. This error also occurs if the instrument
10 is turned on with a strip 106 inserted in it.
The instrument 10 shuts itself off
5 automatically 5 minutes after the last button push or
strip 106 insertion. Automatic shut off occurs
regardless of instrument 10 mode, or the last button
pressed. Depressing ON/OFF button 32 while the instrument
10 is on turns the instrument 10 off.
10 Transducer 80 provides an audible beep: when

the instrument 10 is turned on (0.5 second); when a strip
106 is inserted into opening 104 (0.25 second); whenever
an error message is displayed (three times for 0.1 second
each); at the end of a test to indicate that a result is
15 displayed or an unreacted strip 106 is usable (0.25

second) ; and, whenever either button 32 or button 50 is
depressed as a "key click" sound (two cycle duration) .
Transducer 80 actuation can be enabled/disabled by the
simultaneous actuation of both ON/OFF button 32 and
memory button 50 as the instrument 10 is turned on.

The instrument 10 denotes errors by displaying
the "X" icon in combination with an error message or
other icon. There are two error types: recoverable and
non-recoverable. Strip errors are correctable by removal
of the strip 106 from the instrument 10. All other
errors are non-recoverable and require the instrument 10
to be turned off in order to clear the error.

The following errors are recoverable strip
errors. Removal of the strip will cause the instrument
30 10 to return to the dosed strip prompt: the Bad Strip
error, caused by an improperly reacted strip 106 or a
strip 106 which is degraded in any way as to make its
state indeterminable; and the Strip in Backwards error,
caused by the strip 106 being inserted with its blood
35 application side toward the instrument 10 • s optics .

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The following errors are non-recoverable, as
they are the results of instrument measurement problems:
the Dirty Optics error, which occurs if the instrument
10 's white tile 142 is dirty or degraded, or if the
5 instrument 10 is turned on with a strip 106 already
inserted in it; the Electronics Fault error, which is
caused by the detection of a fault during the instrument
10 1 s power-on self-test: or during a diagnostic check; the
Strip Removed During Test error, which is caused by

10 removing a strip 106 during the performance of a test so
that instrument 10 is unable to complete the test cycle;
and, the Coding error, which is caused by the detection
of a code ROM key 64 read error or a mismatch of the lot
code number read when instrument 10 is turned on with the

15 lot code number read just prior to the calculation of a
glucose result. The only remedy for these errors is to
turn the instrument 10 off.

The instrument 10 provides certain prompt
messages to the user, including: the Strip Removal

20 prompt, by which the instrument prompts the user to

remove a strip 106 by displaying the strip icon and left
arrow (<) icon; and the Dosed Strip prompt, by which the
instrument 10 prompts the user to insert a dosed strip
106 by displaying the strip icon, right arrow (>) icon,

25 and flashing the blood drop icon,. Flashing segments or
icons in any mode of operation are displayed for 0.5
second and off for 0.5 second.

In addition to its normal operating mode for
determining the remissions of reacted test strips, the

30 instrument 10 has a diagnostic software package that is
accessed via installation of a special diagnostic ROM
code key 64. The diagnostic ROM code key 64 is installed
in key housing portion 18 before the instrument 10 is
turned on. Once the instrument 10 is turned on with the

35 diagnostic ROM code key installed, the following

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functions are accessible instead of the normal operating
modes.

Once instrument 10 is turned on in the
diagnostic mode, instrument 10 enters the check strip
5 diagnostic. The instrument displays dl in the glucose
value field, or results field, for one second. After one
second the instrument 10 additionally displays the strip
icon and right arrow icon to prompt the operator to
insert a check strip 106 provided with the diagnostic

10 code ROM key 64. If the user presses memory button 50
during this display, the instrument 10 advances to the
next diagnostic test.

Upon insertion of the check strip, the
instrument 10 measures the remission of the check strip

15 and compares this remission to a target remission value
range stored in the diagnostic code ROM key 64. If the
measured remission agrees with the target value range
then the results field of the display 76 is blank,
transducer 80 beeps once and the user is then prompted to

20 remove the check strip by turning off the right arrow

icon, and turning on the left arrow icon while continuing
to display the strip icon.

Upon removal of the check strip from the
instrument 10 after a successful check, the instrument 10

25 returns to the start of the check strip diagnostic

routine and remains in this routine until the instrument
10 is turned off, or until the user advances to the next
diagnostic routine by pressing the memory button 50.

If the measured remission of the check strip

30 does not match the target value in the diagnostic code
ROM key 64, the instrument 10 beeps three times, CLE
flashes in the results field on display 76, and the error
icon "X M is displayed. The only way to exit this display

...

is to turn instrument 10 off.
35 if the user advances past the first diagnostic

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check by pressing memory button 50 , then the IR
(infrared) sensor check is prompted by displaying d2 in
the results field. After one second, the instrument 10
checks for the presence of a strip in the instrument by
5 using the reagent pad detector. If the instrument 10
determines that a strip 106 is in the instrument 10 , it
prompts the user to remove the strip by displaying the
strip icon and left arrow icon until the strip is
removed.

10 If the instrument 10 detects no strip, the

instrument 10 then reads the IR detector 266. If the IR
detector 266 reads a remission value inconsistent with an
empty strip carrier 120,, 134, then instrument 10 displays
OFF in the results field of display 76 to signify that

15 the IR detector 266 is sensing a strip 106 when none is
present. This display will remain until the instrument
10 is turned off.

If the instrument 10 determines that no strip.
106 is present and that the IR detector 266 sees no strip

20 106, then it prompts the user to insert a strip 106 by
displaying the strip icon and right arrow icon until a
strip 106 is detected by the reagent pad detector 300.
Once a strip 106 is sensed by the reagent pad detector
300, the strip detector 266 is measured. If this

25 measurement is inconsistent with the presence of a strip
106 in the instrument 10 , then the instrument 10 beeps .
three times, the display field displays OFF and the error
X icon flashing until instrument 10 is turned off.

If the IR detector 266 senses the presence of a

30 strip 106 in the instrument 10, then the results field of
display 76 is blank, and the user is prompted to remove
the strip 106 by displaying of the strip icon and left
arrow icon. Orice the strip 106 is removed, the display
76 returns to the d2 display until the user advances to

35 the next diagnostic check by pressing memory button 50 or

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until instrument 10 is turned off.

If the user advances past the customer control
strip diagnostic and past the IR sensor 266 check by
using memory button 50, then the display check will be
5 prompted by displaying d3 in the results field for one
second. After one second, all segments of the display 76
will be displayed for five seconds. Display 76 then
alternates between the d3 display and the all segments
display until the user advances to the next diagnostic
10 check by pressing memory button 50 or until instrument 10

is turned off.

If the user advances past the first three
diagnostic checks by using memory button 50, then the d4
prompt for the transducer 80 check will be displayed in

15 the results field. After one second, transducer 80 beeps
for two seconds regardless of whether the user has
transducer 80 switched off or not. After transducer 80
has beeped for two seconds, it will turn off for one
second and then on for two seconds and so on, until the

20 user advances to the next diagnostic check by pressing
memory button 50 or until the instrument 10 is turned
off.

If the user advances past the first four
diagnostic checks using memory button 50, then instrument
25 10 enters the battery check and prompts the user by

displaying d5 in the results field, and displaying the
battery icon. At the end of one second, the instrument
10 repeats its power-on battery check.

The instrument 10 displays a number based on

30 the following calculation:

■fo-Hwmfc battery voltage x 100
battery low warning voltage
Of course, numbers of less than 100 are displayed if the
battery icon was being displayed prior to entering the d5

35 diagnostic.

This display will remain on until the user

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returns to the first diagnostic check, dl, by pressing
memory button 50 or until instrument 10 is turned off*

The operation of certain software functions of
the disclosed instrument may be better understood by
5 reference to the attached source listing for C 200 and
illustrative data stored in the EEPROM of a typical key
64. In the source listing, CRD or Chemistry Remission
Difference is the amount of remission difference which a
delta must be less than in order to reach the end of
10 reaction (EOR) . CRD is a 12 bit number in bank 1 RAM
which is an input to the function REACTION. The format
of CRD is a 12 bit binary remission multiplied by forty.

IWMI is an 8 bit number in bank 1 RAM which is
an input to function REACTION which determines the number
15 of half second increments of time to delay before taking
the first remission. IWMI is allowed to be from 0 to
255. If IWMI equals 0 f then no delay will occur. If it
equals 1 then one half second of delay will occur, and so
on.

20 TINC is an 8 bit number in bank 1 RAM. TINC is

an input to the function REACTION which determines the
number of half second increments of time which will
elapse between successive remission readings. TINC is
permitted to be from 0 to 255. If it is 0, then one

25 half-second increment of time will elapse. If it is 1,
then two half-second increments will elapse, and so on.

NPS is an input to the function REACTION which
is a 4 bit number in bank 1 RAM. NPS represents the
number of remission readings that will be taken between

30 comparisons. It is allowed to be from 1 to 6. If NPS*1,
then one remission reading is taken between those which
are compared, and so on.

NPSA is an 8 bit number in bank 1 RAM which is
an input to function REACTION. NPSA is a function of

35 NPS. NPSA essentially contains the same information as

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NPS but in a form which is more easily used by the
processor. It is defined as:

NPSA - (NPS+1) * 8
IWMA is an 8 bit bank 1 RAM number. IWMA is an
5 input to function REACTION. IWMA controls the number of
comparisons that the EOR portion of the algorithm will
make before it terminates. IWMA is permitted to be from
1 to 255. If IWMA equals 1, then only one comparison
will be made. If IWMA equals 2, then a maximum of two
10 will be made, and so oh.

ERS is a 1 bit number in bank 1 RAM which is an
input to function REACTION. ERS causes the MAX_F flag to
be set if the function REACTION reaches EOR by reaching
IWMA.

15 EORREM l is a 32 bit floating point number in

bank 1 RAM which contains the last remission taken by
function REACTION. EORREM 1 is an output of function '
REACTION.

EORCOUNT is an 8 bit bank 1 RAM number which
20 contains the number of comparisons done during EOR. It
will never equal 0. It will always be from 1 to 255.
eorcounT is an output of function REACTION.

MA3L.F is an output of function REACTION. MAX_F
is a l bit bank 1 RAM number. MA3CF is set equal to 1 if
25 EOR is reached by the number of comparisons equalling

IWMA and ERS is also 1. If these conditions are not met,
then MAX_F is cleared to zero.

TRACE_F is a 1 bit bank 0 (zero) RAM input to
module REACTION which indicates that the meter is in
30 TRACE MODE. In TRACE MODE, all remission readings are
sent out the I/O port.

SE_F is a 1 bit bank 1 RAM number which is an
output. If SE_F is set, a strip error has occurred. Two
conditions can cause this: (1) EORREM 1 less than COL or
35 greater than COH; or (2) EOR reached by finding a delta

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less than CRD, but the last 2 remissions taken did not
have deltas less than CRD,

COL is a bank 1 RAM location. Its format is a
12 bit binary remission multiplied by 40. All EORREM 1
5 values found by this function are compared to this

number. If EORREM 1 is less than COL, then SE_F is set.

COH is a bank 1 RAM location. The format is a
12 bit binary remission times 40. All EORREM 1 values
found by this function are compared to this number. If
10 EORREM 1 is greater than COH, then SE_F is set.

REACTION ASSESSMENT

Summary

15 Reaction Assessment is responsible for

observing the strip adaptor and determining when the
remission of the object in the strip adapter has reached
the EOR. It does this by periodically taking full power
chemistry pad remissions and analyzing these against

20 parameters found in the external ROM. The final

remission is placed in a reserved location in RAM. In
addition, Reaction Assessment determines how many
comparisons were made during the search for EOR. During
the operation of this module, a rotating arrowhead is

25 displayed on the LCD display as a means of indicating
that this module is operating. This module also
transmits the value of each remission taken out the
serial port if TRACE_F is set. If the MEM button is
pushed during the execution of this module, then control

30 passes to the STRIP INTEGRITY module and Reaction
Assessment is aborted.

More Detailed Explanation

This function is responsible for observing the
strip adapter and determining when EOR occurs or if the

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MEM button is pushed. In addition, Reaction Assessment
displays a rotating arrow on the LCD as a means of
providing a visual indication that the meter is busy. It
also outputs each remission taken if TRACE.F is set.
5 Reaction Assessment begins by clearing the LCD

and darkening a single arrowhead. The first arrowhead
darkened is not specified and will vary indeterminately.
For the duration of the execution of this function the
LCD will change its display every half second. The

10 display will change by lightening the arrowhead that is
currently dark and darkening the arrowhead which is
adjacent to it in the clockwise direction. At the
completion of this function the duration of time since
the LCD display was changed will be between approximately

15 20 and 300 msec. A typical time will be around 100 msec.
This duration varies with the time required to take a
remission and whether TRACE_F is set or not. It is
intended that if a continuation of the rotating arrowhead
display is desired following the completion of this

20 function, then it is necessary to wait another half

second before changing the LCD display. In addition, SE
F is cleared at this time.

Reaction Assessment employs the power
conservation module so that when it is not actively

25 taking remission readings or doing calculations it puts
the meter in a power conservation mode which minimizes
power consumption yet still permits the meter to respond
immediately to any event which can cause a termination of
power savings.

30 The second thing that this function does is to

examine RAM location IWMI to determine the amount of
initial delay before taking the first remission reading.
IWMI is an 8 bit binary integer. Each count of IWMI
represents, a half second of delay. IWMI may be from 0 to

35 255. 0 implies no delay and 255 implies 255 half seconds

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of delay. An example of IWMI is illustrated in Fig. 11.
Here, IWMI has a value of 3. This causes 1.5 seconds of
delay from the start of this function to where the first
remission is taken.
5 Once the requirements of IWMI have been met,

then a single, full power remission is taken on the
chemistry channel. This remission is referred to as the
first remission reading.

The next task that the function REACTION

10 performs is a TRACE CHECK. This involves checking the 1
bit RAM location TRACE_F. If this location holds a 0,
nothing happens. If it holds a 1, then the remission
just taken is sent out the serial port as a 4 byte
floating point number (least significant byte first) in

15 the PC communication format.

The EOR portion of this .function is conducted
at this time. To reach EOR, one of two events must
occur. Either a comparison of two remissions is found to
have a change, or delta, which is less than CRD, or a

20 time-out occurs after a number of comparisons equal to
IWMA has been made.

Enti Qt Reaction fry achieving » PBfrTA < CRD

25 CRD is a number found in RAM which is a limit

for how small delta must be in order to constitute EOR.
Delta is the result of subtracting the most recent
remission from a prior remission determined by ROM code
key 64 parameter NPS. The comparison between CRD and a

30 delta is made as follows:

Is I delta I < I CRD I ?
If the answer to this question is yes, then EOR has been
reached. If not, then another comparison must be made.
The timing for these events can best be

35 described in connection with Fig. 11. The first

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remission reading has already been taken (time -1.5
sec.)- The amount of delay until a subsequent remission
reading is taken is controlled by TINC. If TINC equals

0, then the delay increment will be one half second. If
5 TINC equals 1, then 2 increments of one half second will

occur. TINC is permitted to vary from 0 to 255, so it
will provide delays of from .5 to 128 seconds. The
example in Fig. 11 shows a TINC of 1 which causes a delay
of two one half second increments between remission
10 readings.

A delta is formed by comparing two remission
readings. The two remissions compared are determined by
RAM locations NPS and NPSA. NPSA - (NPS+1)*8. NPS
refers to how many previous remissions will be skipped
15 before using a remission to form a delta. If NPS eqdals

1, as in the example of Fig. 11, then one remission is
skipped. For this example, the first delta is calculated
after the third remission reading is taken. The delta is
calculated by subtracting the first remission reading

20 from the third remission reading. NPS is permitted to be
from 0 to 6, permitting from 0 to 6 remission reading to
be skipped between comparisons. If, for example, NPS=6,
six remission readings are skipped, and the remission
reading which was detected seven remission readings ago

25 is the one that is used to calculate delta.

RAM location EORCOUNT is used to keep track of
how many comparisons are made during this function. At
the beginning of this function, EORCOUNT is set equal to
zero. RAM location EORCOUNT is incremented by 1 each

30 time a comparison is made until a delta less than CRD is
found. If a delta is found that is less than CRD, then
the software decides that EOR has been reached. In the
example provided in Fig. 11, a delta less than CRD was
reached when the fourth reading was taken. Therefore,

35 the final EORCOUNT value for this example is 2.

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Once the EOR is reached by finding a delta less
than CRD, one more remission reading is taken after a
time interval controlled by TINC. Following this
remission, a Trace Check remission is read. This Trace
5 Check remission is also compared to a previous remission
controlled by NPSA. EORCOUNT is not incremented when
this remission is read and its corresponding delta is
calculated. If this delta is less than CRD, then the
remission just taken will be stored at RAN location

10 EORREMl. The software will then continue as described
following the next paragraph. If this delta is not less
than CRD, then the meter will continue as described in
the next paragraph. Fig. 11 does not illustrate this
condition since the fifth reading is quite low and the

15 delta (THIRD DELTA) created thereby is greater than CRD.
However, if THIRD DELTA had been less than CRD, then the
fifth reading would have been the last and would
illustrate this condition.

The meter next takes another remission reading

20 immediately without waiting for TINC. This remission is
compared to the same remission as is the remission taken
after delta less than CRD. The example in Fig. 11 shows
a delta being created between the third reading and the
sixth reading. If the delta is not less than CRD, then

25 the 1 bit RAM location SE_F is set. EORCOUNT is not
incremented when this remission is read and its
corresponding delta is calculated. This remission is
stored at RAM location EORREMl. A Trace Check is
performed. The function now proceeds as described below.

30 Each time a comparison is made, the RAM

location EORCOUNT is incremented by 1. EORCOUNT is
zeroed at the beginning of this function. If so many
comparisons are made that EORCOUNT equals IWMA, then EOR
will have been reached, if this happens, and if the 4

35 bit RAM location ERS equals 1, then the 1 bit RAM

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location MAX_F is set. Otherwise MAX_P is cleared by
this function, regardless of how this function
terminates. An example of this type of EOR is given in
Fig. 12. Here, IWMA equals 5. After five comparisons
5 (deltas) are calculated and none of these deltas are
found to be less than CRD, EOR is reached.

Once EOR has been found by reaching IWMA, then
another remission is taken after TINC has elapsed.
Following this remission, a Trace Check remission is read
10 immediately. This remission is then written into RAM

location EORREMI.

Regardless of how EOR was reached, this
function now proceeds by outputing 4 bytes of BEH if the
TRACE_F is set. This indicates to a PC that the function

15 REACTION is completed.

The last thing REACTION does is to check if the
EORREMI value is greater than RAM number COL and less
than RAM number COH. If EORREMI is not between COL and
COH then the SE_F bit in RAM is set. If EORREMI is

20 between COL and COH then the SE_F bit is not modified. It
is possible that EOR was reached by finding a delta less
than CRD, and that the last two remissions did not meet
the CRD retirements but the last remission was within
the limi ts set by COL and COH. In this case, a strip

25 error is still considered to have occurred, and the SE_F

bit remains set.

Throughout this entire function, the meter is
alert for a pressing of the MEM button. If the MEM
button is pressed, then a branch to the STRIP INTEGRITY
30 function is performed. This terminates the Reaction
Assessment function.

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Claims:

1. A method for verifying the operating
accuracy of an instrument for detecting the concentration

5 of a medically significant component of a body fluid, the
instrument operating by determining the remission of a
reacted chemistry contained on a substrate after the
chemistry has reacted with the medically significant
component of the body fluid, the instrument including a

10 radiation source, a radiation detector and a pathway from
the radiation source to the chemistry and from the
chemistry to the radiation detector when the substrate is
properly inserted into the instrument, the remission of
the chemistry determining the radiation detected by the

15 radiation detector, the method comprising the steps of
inserting into the instrument a verification substrate
having a known remission, energizing the radiation
source, detecting the remission from the verification
substrate, and displaying on a display associated with

20 the instrument an indication that the known remission was
detected by the radiation detector.

2. The method of claim 1 wherein the
instrument comprises a port for removably receiving
non-volatile memories containing instrument- initializing

25 parameters related to the characteristics of specific

batches of the chemistry, the chemistry being subject to
fluctuation from batch to batch, and further comprising
the steps of providing a non-volatile instrument
operating accuracy verifying memory in which parameters

30 related to the characteristics of the verification
substrate are stored, and inserting the operating
accuracy verifying memory before the step of. inserting
the verification substrate into the instrument.

3. The method of claim 2 wherein the

35 instrument further includes a second radiation source, a

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second radiation detector and a second pathway from the
second radiation source to the substrate and from the
substrate to the second radiation detector when a
substrate is inserted into the instrument, the method
5 further comprising the steps of energizing the second

4. The method of claim 3 wherein the display
provides a number of symbols and further comprising the
step of energizing multiple symbols of the display after
the step of displaying on the display an indication

15 whether a substrate is inserted into the instrument based
upon the remission detected by the second radiation
detector.

5. The method of claim 3 Wherein the
instrument further comprises an audio source and further

20 comprising the step of energizing the audio source after
the step of displaying on the display an indication
whether a substrate is inserted into the instrument based
upon the remission detected by the second radiation
detector.

25 6. The method of claim 1 wherein the

instrument further includes a second radiation source, a
second radiation detector and a second pathway from the
second radiation source to the substrate and from the
substrate to the second radiation detector when a

30 substrate is inserted into the instrument, the method
further comprising the steps of energizing the second
radiation source, detecting the remission therefrom using
the second radiation detector, and displaying on the
display an indication whether a substrate is inserted

35 into the instrument based upon the remission detected by

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the second radiation detector.

7. The method of claim 6 wherein the display
provides a number of symbols and further comprising the
step of energizing multiple symbols of the display after

5 the step of displaying on the display an indication that
the known remission was detected by the radiation
detector.

8. The method of claim 7 wherein the
instrument further comprises an audio source and further

10 comprising the step of energizing the audio source after
the step of displaying on the display an indication
whether a substrate is inserted into the instrument based
upon the remission detected by the second radiation
detector.

15 9. A method for testing the operation of an

instrument for detecting the concentration of a medically
significant component of a body fluid, the instrument
operating by determining the remission of a reacted
chemistry contained on a substrate after the chemistry

20 has reacted with the medically significant component of
the body fluid, the instrument including a radiation
source, a radiation detector and a pathway from the
radiation source to the substrate and from the substrate
to the radiation detector when the substrate is inserted

25 into the instrument, the method comprising the steps of
energizing the radiation source, detecting the remission
therefrom, and displaying on a display associated with
the instrument an indication whether a substrate is
inserted into the instrument based upon the detected

30 remission.

10. The method. of claim 9 wherein the display
provides a number of symbols and further comprising the
step of energizing. multiple symbols of the display after
the step of displaying on the display an indication
35 whether a substrate is inserted into the instrument based

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upon the detected remission.

11. The method of claim 9 wherein the
instrument further comprises an audio source and further
comprising the step of energizing the audio source after

5 the step of displaying on the display an indication

whether a substrate is inserted into the instrument based
upon the detected remission.

12. Apparatus for verifying the operating
accuracy of an instrument for detecting the concentration

10 of a medically significant component of a body fluid, the
instrument operating by determining the remission of a
reacted chemistry contained on a substrate after the
chemistry has reacted with the medically sighif icaht
component of the body fluid, the instrument including a

15 radiation source, a radiation detector and a pathway from
the radiation source to the chemistry and from the
chemistry to the radiation detector when the substrate is
properly inserted into the instrument, the remission of
the chemistry determining the radiation detected by the

20 radiation detector, the apparatus comprising a

verification substrate having a known remission for
inserting into the instrument, means for energizing the
radiation source, means for receiving the remission
detected by the radiation detector from the verification

25 substrate, and a display associated with the instrument
for displaying an indication that the known remission was
detected by the radiation detector.

13. The apparatus of claim 12 wherein the
instrument further comprises a port for removably

30 receiving non-volatile memories containing

instrument-initializing parameters related to the
characteristics of specific batches of the chemistry, the
chemistry being subject to fluctuation from batch to
batch, and a non-volatile instrument operating accuracy

35 verifying memory for storing parameters related to the

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characteristics of the verification substrate, the
operating accuracy verifying memory adapted for insertion
into the port.

14. The apparatus of claim 13 further
5 comprising a second radiation source, a second radiation
detector and a second pathway from the second radiation
source to the substrate and from the substrate to the
second radiation detector when a substrate is inserted
into the instrument, means for energizing the second

10 radiation source, the second radiation detector
detecting the remission therefrom and the display
displaying an indication whether a substrate has been
inserted into the instrument based upon the remission
detected by the second radiation detector.

15 15. The apparatus of claim 14 wherein the

display provides a number of symbols and further
comprising means for energizing multiple symbols of the
display after an indication whether a substrate is
inserted into the instrument based upon the remission

20 detected by the second radiation detector.

16. The apparatus of claim 14 further
comprising an audio source and means for energizing the
audio source after an indication whether a substrate is
inserted into the instrument based upon the remission

25 detected by the second Radiation detector.

17. The apparatus of claim 12 further
comprising a secfond radiation source, a second radiation
detector and a second pathway from the second radiation
source to the substrate and from the substrate to the

30 second radiation detector when a substrate is inserted
into the instrument, means for energizing the second
radiation source, the second radiation detector detecting
the remission therefrom, and the display displaying an
indication whether a substrate has been inserted into the

35 instrument based upon the remission detected by the

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second radiation detector.

18. The apparatus of claim 17 wherein the
display provides a number of symbols and further
comprising means for energizing multiple symbols of the

5 display after an indication that the known remission was
detected by the radiation detector.

19. The apparatus of claim 18 further
comprising an audio source and means for energizing the
audio source after the display displays an indication

10 whether a substrate is inserted into the instrument based
upon the remission detected by the second radiation
detector.

20. Apparatus for testing the operation of an
instrument for detecting the concentration of a medically

15 significant component of a body fluid, the instrument
operating by determining the remission of a reacted
chemistry contained on a substrate after the chemistry
has reacted with the medically significant component of
the body f luid, the instrument including a radiation

20 source, a radiation detector and a pathway from the

radiation source to the substrate and from the substrate
to the radiation detector when the substrate is inserted
into the Instrument, the apparatus comprising means for
energizing the radiation source, means for detecting the

25 remission therefrom, and a display associated with the
instrument for displaying an indication whether a
substrate is inserted into the instrument based upon the

detected remission.

21. The apparatus of claim 20 wherein the
30 display provides a number of symbols and further

comprising means for energizing multiple symbols of the
display after an indication whether a substrate is
inserted into the instrument based upon the detected
remission.

35 22. The apparatus of claim 20 further

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comprising an audio source and means for energizing the
audio source after an indication whether a substrate is
inserted into the instrument based upon the detected
remission.

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JFM.I

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3/12

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FIG. 4

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5/12

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6/12

PCT/US92/01733

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PCT/US92/01733

8/12

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10/12

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% REMISSION

. FIRST DELTA '
NPS*1,NPSA«I6^

1st . |
READING

— SECOND DELTA -
NPS=1,NPSA=I6

_ THIRD DELTA
NPS»i, NPSA=I6"

i 2nd
READING

4th
READING ,

3rd

I | READING I

-1WM1* 3 >VTING=lrvU-TINC=l-*-U-TINC»i

i ^delS"* - ^ Bth
, UtLrA | i READING

5th
jREADING

i.O 1.5

.REACTION
ASSESSMENT
BEGINS HERE

i I i i | i ■ ■

2.0 2.5 3.0 3.5 4.0 4.5 5.0 5^5
TIME (HALF SECOND INCREMENTS)^

EOR BEGINS
HERE

I W MA >2
ERS'IORO
E0RC0UNT=2
MAX«F»0

TOTAL NUMBER OF REMISSIONS TAKEN =5
EOR REM 1 RECEIVES THE 5TH READING

EOR IS
FINISHED
HERE

''FIG. M

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% REMISSION

4th
DELTA

2.0 2.5 3.0 3.5 40 4.5 5.0
TIME (HALF SECOND INCREMENTS)

5th
DELTA

FINAL
REMISSION

5,5 6j0

REACTION ASSESSMENT
AND EOR BEGIN HERE.

EOR

IS FINISHED
HERE

IWMA=5
ERS = i

E0RC0UNT=5
MAXi_F=i

TOTAL NUMBER OF REMISSIONS TAKEN
E0RREM1 RECEIVES THE 13th READING

TINC'O
IWMhO
NPS *6
N PSA =56

FIG. 42

INTERNATIONAL SEARCH REPORT

— — ~~ tntwnrtjonrt Appl ication No. PCT/OS92/01733

L ClAS8inCATI0 N OP SUBJECT MATTER (If e.^ . ^.> « oation . vmKwl . „ np , v . Indicaf .

According to International Patent Classification (IPC) or to both National aerification and IPC

iST^ 5 '' ?Si» 21 /00 r 21/03, 21/47, 21/55, 31/00, 33/00

TO CL : 436/34, 164, 165; 422/S8, 68.1, ^Tos,' 82To9: 356/446
! jT HELPS SEARCHED —————— —

Minimum Documentation Scorched*

I Classification Systorr

Ctatgjfioatlon Symbols

U.S.

356/445? 4 446 5 ' " 4 / 1$5 '" 422/5 *' 58 ' "'^ 82 ' 05 '

Documentation Starched other than Minimum Documentation
to the extant that euch Documents are included in tha Raids Searched 5

lit. DOCUMENTS CONSIDERED TO BE RELEVANT "

[Category

CrtatlonofDcxaimem > 1 *w^

,17

X/Y,P

|A,P

figst'x 4 £ 6 3 653 (Strohmeier et al) 30 1*87, see

Sai; i!53! <Phlllips et al) 22 1991 - s -

entire ffi? (Kh ° ja et al) 08 ■«

2; kfc"^^ et al) 10 September » M -

SeuNBt 934,817 (Ga8senhilb er) 19 June 1990, see entire

entir^^i" <Ashley et al) 05 January 1982, see
tocuroenV 989 ' 383 (Paul8on) 02 N^en^er 1976, see.entire

1-13, 16-24/
14-15

14-15

all
all
all
all
all
all
all

* Spade! categories of cited documents;!*

V ***** - --tar*.

V doojmer* which may throw doubts on priority cieJm(s)

f/wriercrtai»nofotrwepecW
£She?mea^^

f later document published after the international filing
date or priority date and not in oonfHct with the
?JW>ttcetion but cited to understand the principle or
theory underlying the invention

"X* . document of particular relevance; the claimed
invention cannot be considered novel or cannot be
considered to involve an inventive step

9ym of particular relevance; the claimed

taventfon cannot be considered to involve en
inventive etepwhan the document is combined with
ow or more other such dooumema, such combination
being obvious to a person stifled in the art

^ document membar of tha same patent f amity

IV. CERTIFICATION

Date of the Actual Completion of the International Search 2

19 May 1992

Signature ofAtrt^att Officer » 7/

ternattonai Searching Authority 1

ISA/US

Form PCT/ISA/210 (second sheet) {May 1986) ft

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Full text of "USPTO Patents Application 10687850"

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